Whether a drug manufacturer that has complied with the Food and Drug Administration’s labeling requirements can still be liable under state product liability laws on grounds that the label was inadequate.
In 2000, Diana Levine was treated with Phenergan to relieve nausea caused by a migraine headache. The drug was incorrectly administered into Levine’s vein, causing gangrene that ultimately led to the amputation of part of her arm. Levine sued Wyeth, Phenergan’s manufacturer, in Vermont Superior Court and the Supreme Court of Vermont on claims of negligence and products liability, arguing that Phenergan’s label was inadequate in warning consumers about its possible risks. Wyeth, on the other hand, argued that federal law preempted Levine’s state law claims, as state law directly conflicted with the requirements of the Federal Food, Drug and Cosmetic Act. With both lower courts ruling in favor of Levine, this case gives the Supreme Court an opportunity to further define the federal preemption doctrine by clarifying whether a drug manufacturer can be liable under state law after complying with the labeling requirements of the Food and Drug Administration. Stakeholders on both sides argue that the outcome of this case will have a direct impact on the kind of information included on drug labels and as such, has serious implications for patient safety and public health.
Questions as Framed for the Court by the Parties
Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration ("FDA") pursuant to FDA's comprehensive safety and efficacy authority under the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe for use.
In April of 2000, Diana Levine sought medical treatment for symptoms, such as pain and nausea, caused by a migraine headache. See Levine v. Wyeth, 944 A.2d 179, 182 (Vt. 2006). To relieve her nausea, Levine was given two injections of Phenergan, a drug manufactured by Wyeth. See id. The first injection was given via intramuscular injection. When Levine’s nausea continued she was given a second injection of Phenergan, this time through an IV-push. See id. An IV-push is a procedure through which medication is administered directly into a vein in order to provide the patient with faster relief. See Brief for Petitioner, Wyeth, at 11–12. However, the Phenergan given via IV-push was incorrectly administered and resulted in the drug being injected directly given into an artery rather than a vein. See Wyeth, 944 A.2d at 182. This error caused major damage to Levine’s artery and caused severe gangrene in her hand and forearm. See id. As a result, Levine’s hand and forearm were amputated. See id.
Levine sued Wyeth in Vermont Superior Court, alleging negligence and products-liability. See Wyeth, 944 A.2d at 182. (Prior to Wyeth,Levine settled a lawsuit against the clinic. See Adam Liptak,Drug Label, Maimed Patient and Crucial Test for Justices, N.Y. Times, September 19, 2008.) The issue in Wyeth turned on whether or not Wyeth had adequately warned consumers and health care providers about the risks associated with administering Phenergan directly into an artery. See Wyeth, 944 A.2d at 182.Levine argued that Phenergan’s label was inadequate because it did not provide sufficient warning about the risks of injecting Phenergan directly into a vein. See Id. In contrast, Wyeth argued that its federal obligations under the Federal Food and Drug Cosmetic Act (“FDCA”) shielded it from state law claims regarding the adequacy of drug labels. See id.The FDCA, among many other things, prescribes rules for drug labeling, including how labels are approved and what information they must include. See Brief for Petitioner at 8–11. The trial judge ruled for Levine and instructed the jury that “the label’s compliance with FDA requirements did not establish the adequacy of the warning or prevent defendant [Wyeth] from adding to or strengthening the warning on the label.” Wyeth, 944 A.2d at 182. The jury ruled against Wyeth on both the negligence and products liability counts and awarded Levine $7.4 million in economic and noneconomic damages. See id.The parties agreed to reduce this amount to approximately $6.8 million. See id.
Wyeth appealed this decision to the Supreme Court of Vermont, arguing that Levine did not have a valid state claim because federal law prevented Wyeth from changing the drug label. See Wyeth, 944 A.2d at 182–83. As such, Wyeth argued that Levine’s state law claim was preempted and never should have gone to the jury. See id.The Supreme Court of Vermont affirmed the trial court’s judgment in favor of Levine, holding that the state claim was not preempted. See id. at 183. Wyeth then petitioned the United States Supreme Court for certiorari, which was granted on January 18, 2008. 128 S.Ct. 1118.
Background: Federal Drug Regulation
The federal government, through the Food and Drug Administration (“FDA”), has controlled the standards for the labeling of prescription drugs since Congress passed the Federal Food and Drugs Act of 1906 (“FFDA”). See Pub. L. No. 59-384, 34 Stat. 768 (1906). The Act allowed the federal government to, among other things, seize misbranded prescription drugs and sue the manufacturer. See Id. at §§ 1, 5, 8, 10. The Act deemed a drug “misbranded” if its “package or label . . . b[ore] any statement, [or] design . . . which [is] false or misleading . . .” Id. at § 8.
In 1938, reacting to complaints from journalists, consumer protection agencies, and the FDA itself, Congress replaced the FFDA with the Federal Food, Drug, and Cosmetic Act (“FDCA”), which is still in force today. See History of the FDA: 1938 Food, Drug, and Cosmetic Act; Pub. L. No. 75-717, 52 Stat. 1040 (1938). The purpose of the FDCA is to provide greater protection to consumers and the public health. See Brief for Respondent at 4. The labeling requirements for drugs include “adequate directions for use” and “adequate warnings . . . against unsafe dosage or methods or duration of administration or application, in such manner and form, as are necessary for the protection of users . . .” Pub. L. No 75-717 § 502(f).
Today, the FDA regulates all prescription drug labeling. See Brief for Petitioner at 8. The FDA has extensive requirements for drug labels, including that the “drug contain a summary of the essential scientific information needed for the safe and effective use of the drug” and that the labeling is “informative and accurate” and not “false or misleading.” 21 C.F.R. § 201.56(a), (b). All prescription drug labels must also contain other information, such as the indications and usage, warnings, precautions, adverse reactions, dosage, and administration of the drug. See id. at § 201.56(d)(1).
To ensure that drug companies comply with all drug labeling requirements, a drug manufacturer must first submit a New Drug Application (“NDA”) before selling the drug, upon which the FDA will review the prescription drug label. See Brief for Petitioner at 6, 9; Brief for Respondent at 5. The FDA will only approve a drug label if the drug is safe for the uses described on its label. See 21 U.S.C 355(d). After the FDA has approved a drug’s label, the manufacturer of the drug may not change the existing label without FDA approval unless the manufacturer acquires “newly acquired information,” in which case the manufacturer may “add or strengthen an instruction about dosage and administration that is intended to increase the safe use of the product.” See Brief for Petitioner at 9; 21 C.F.R. § 314.70(c)(6)(iii).
Possible Basis of Preemption: Conflict Between State Law and Federal Law
As an initial matter, Wyeth bases its reasoning on the premise that federal law preempts Levine’s state-law claims. See Brief for Petitioner at 4. The Supremacy Clause of the United States Constitution states that federal law is the “supreme law of the land.” U.S. Const. art. VI, cl. 2. Wyeth argues that in practice, the Supremacy Clause means that if state law conflicts with federal law, then that state law is preempted by the federal law (i.e. federal applies and state law does not). See Brief for Petitioner at 26 (quoting Cipollone v. Liggett Group, Inc., 505 U.S. 504, 516 (1992)). Wyeth contends that where, such as here, federal law preempts state law, it is impossible to comply with both federal and state laws. See id.
Specifically, Wyeth argues that federal law preempts Levine’s state-law claims in two distinct ways. See Brief for Petitioner at 26. First, Wyeth claims that had it changed the label on Phenergan, Wyeth’s action would have conflicted with the FDCA. See Id. Wyeth claims that the label of a prescription drug cannot be changed without FDA approval, and that the Vermont Supreme Court erred when it held that Wyeth could have made changes without FDA approval. See Id. at 26–27. Because a manufacturer can only change a drug label if it acquires new information, and because Wyeth did not acquire any new information about the risks of Phenergan, Wyeth argues that it would have had no authorization to change the drug’s label without FDA approval. See Id. at 3, 27.
In response, Levine argues initially that there is a presumption against preemption; that is, Wyeth must show that there is “clear congressional intent” to have federal law preempt state law in this situation. Brief for Respondent at 21. Here, Levine argues, neither the FDCA nor its amendments contain an express provision for preemption for cases involving prescription drugs. See Id. at 1, 21. In addition, Levine points to other cases involving medical devices to support her argument that Congress would have stated explicitly if it wanted preemption to apply here. See Id. Indeed, Levine argues that the absence of an explicit provision “strongly signals [Congress’s] intent to preserve state-law remedies against pharmaceutical manufacturers.” Id. at 27–28.
Moreover, Levine argues, it would not have been impossible for Wyeth to comply with both federal and state law simultaneously. See Brief for Respondent at 21. Levine argues that Wyeth could have strengthened the warning on Phenergan’s label without incurring federal liability. See Id. at 22. Levine argues that there were two points at which Wyeth could have strengthened or added to Phenergan’s warning label. See Id. at 22, 32. First, Levine argues, Wyeth could have changed the label after it had submitted the NDA for Phenergan to the FDA, but before the FDA had approved it. See Id. at 22, 32–33. Then, the FDA would still have been able to approve all aspects of the label, and no provision in the FDCA forbids changing the labeling at that point in the process. See Id. Alternatively, Levine argues that Wyeth could have changed the label after the FDA approved it, as long as the changes were consistent with FDA regulations. See Id. at 22, 32.
Possible Basis of Preemption: State Law as an Obstacle to Congress’ Goals
Wyeth also contends that federal law preempts Levine’s state-law claims because the claims “stand as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.” See Brief for Petitioner at 27 (citing Hines v. Davidowitz, 312 U.S. 52, 67 (1941)). To support this claim, Wyeth explains that when the FDA approves new drugs, the agency is not just setting the minimum safety standard with which a drug manufacturer must comply. See Id. at 28. Instead, the FDA is performing a balancing act, with the risk that the drug poses and the goal of making valuable treatments available to the public. See Id. at 4, 28. This balancing, Wyeth contends, is critical to securing the availability of such treatments, as well as ensuring that juries do not “focus on a single patient’s catastrophic injury, rather than the potential benefits of the drug to the public as a whole.” See Id. at 28. Moreover, Wyeth contends that allowing state law to apply in cases such as the one here creates an obstacle to Congress’s goals by “second-guessing” the determination of the FDA, an expert agency. Id. 4, 28.
Levine, however, argues that the decision of the Vermont Supreme Court is not an obstacle to Congress’ goals. See Brief for Respondent at 23. On the contrary, Levine argues, Vermont state law (and any state law that has strict requirements for drug labeling) actually provides an extra incentive for drug manufacturers to comply with federal law. See Id. at 23, 45–46. Because a drug is not widely available until after the FDA has approved it, “[s]tate-law actions . . . induce manufacturers to evaluate and act on risk information they receive.” Id. at 49. In response to Wyeth’s argument that the FDA already balanced the risks and benefits of Phenergan, Levine contends that Wyeth never produced any evidence that the “FDA ever weighed the risks and benefits of IV-push administration of Phenergan” with some other type of administration of the drug. Id. at 24. Wyeth, however, responds to Levine’s contention by arguing that it provided all relevant information about the risks of IV-push administration to the FDA. See Reply Brief for Petitioner at 2.
This case will determine whether drug manufacturers or the federal government are ultimately responsible for the adequacy of drug labeling. According to Petitioner Wyeth, the Federal Food,Drug, and Cosmetic Act (“FDCA”) gives the Food and Drug Administration (“FDA”) complete control over the content of drug labels and thus exempts drug manufacturers from liability under state law for claims related to the adequacy of labels. See 21 U.S.C. 301; Brief for the Petitioner, Wyeth, at 4. In contrast, respondent Levine argues against federal preemption on grounds that the FDA establishes only minimum labeling requirements and leaves manufacturers free to modify labels as necessary to comply with state products liability laws. See Brief for the Respondent, Diana Levine, at 31. According to the thirty amicus briefs in this case, the outcome of this case will have a serious impact on public health and safety.
Who is ultimately responsible for drug labeling decisions?
Of great concern to the parties and the stakeholders in this case is who is ultimately responsible for determining the adequacy of drug labels. The decision of what to include on drug labels involves careful balancing of the risks and benefits to a patient of using a certain drug. See Brief for Petitioner at 2; Brief of Amici Curiae Former FDA Commissioners Dr. Donald Kennedy and Dr. David A. Kessler in Support of Respondent at 7. Amici in support of Wyeth, such as the U.S. Chamber of Commerce, urge the Supreme Court to give the FDA almost exclusive control over this balancing process because of the level of expertise required to make decisions that promote patient safety and health. See Brief for Amicus Curiae United States Chamber of Commerce in Support of Petitionerat 37, 39. In addition, according to amicus United States, the FDA’s expertise in evaluating the risks and benefits of various labeling requirements would be undermined by allowing drug manufacturers to modify labels without FDA approval. See Brief for Amicus Curiae United States in Support of Petitioner at 8, 18. Furthermore, pharmaceutical companies warn that by allowing state products liability claims, juries and not the FDA end up determining the adequacy of drug labels. See Brief for Amici Curiae PhRMA and Bio in Support of Petitioner at 4. According to other amici, including the Generic Pharmaceutical Association, juries are not equipped to engage in the kind of technical balancing required in drug injury cases, and juries are more inclined to focus on the plight of the individual plaintiffs rather than on the overall impact of labeling decisions on public health. See Brief for Amicus Curiae Generic Pharmaceutical Association (“GPA”) in Support of Petitioner at 1-2; Brief for Amicus Curiae DRI – The Voice of the Defense Bar (“DRI”) in Support of Petitioner at 20.
In contrast, former FDA Commissioners argue that public health is best protected by making drug manufacturers, and not just the FDA, responsible for changing drug labels as necessary for patient safety. See Brief of Amici Curiae Former FDA Commissioners in Support of Respondent at 2. These former Commissioners argue that exposing drug manufacturers to state law liability promotes health and safety by supplementing the FDA’s approval process and providing additional incentives for drug companies to disclose all risks related to a drug’s use. See id. at 3. Similarly, the AARP and other patient advocacy organizations argue that the FDA alone cannot provide adequate protection to the public with respect to drug safety. See Brief of Amici Curiae AARP, et al. in Support of Respondent at 3.
What impact will the outcome of this case have on public health?
Stakeholders involved in this case argue that a favorable outcome for their side is critical to protecting public health. The California Medical Association argues that federal preemption in drug labeling cases threatens public health by decreasing incentives for drug manufacturers to disclose safety information or alter labels as additional information about drug risks becomes available. See Brief of Amicus Curiae California Medical Association in Support of Respondent at 12. Similarly, the New England Journal of Medicine argues that the threat of state tort liability is sometimes necessary to get drug companies to disclose newly discovered dangers associated with certain drugs. See Brief for Amicus Curiae New England Journal of Medicine Editors and Authors in Support of Respondent at 40. In addition, forty-seven states joined in filing an amicus brief arguing that preemption in cases like this wouldundermine states’ important responsibility to safeguard the public health. Brief for Amici Curiae Vermont, et al. in Support of Respondent at 14.
Conversely, amici in support of Wyeth argue that exposing drug manufacturers to liability in state courts will threaten public health by causing over-warning on drug labels. See Brief for PhRMA and BIO at 15-16.Specifically, PhRMA argues that “the threat of liability under state law encourages manufacturers to warn physicians and patients about risks that are speculative and scientifically unsupported,” which can undermine the credibility of drug warnings, delays research on new drugs, and discourage patients and health care providers from using otherwise beneficial drugs. See Brief for PhRMA and BIO at 4, 14; Brief for DRI at 2. Furthermore, the Washington Legal Foundation and American College of Emergency Physicians cite cases in which over-warning has led to negative health outcomes for the public, including outbreaks caused by excessive warnings related to vaccines. See Brief for Amici Curiae Washington Legal Foundation and American College of Emergency Physicians (“WLF”) in Support of Petitioners at 22-23.
“Federal pre-emption is the fiercest battle in products liability law today” and with this decision the Supreme Court will take another step in clarifying this complex doctrine. See Adam Liptak, Drug Label, Maimed Patient and Crucial Test for Justices, N.Y. Times, September 19, 2008. As this case deals with preemption doctrine generally, the Court’s decision may affect the “potentially billions of dollars” at stake in product-liability lawsuits covering a wide range of products. See Scott Hensley, Plaintiffs’ Lawyers Fight Restrictions on Product-Liability Suits, The Wall Street Journal, August 13, 2008.
This case will resolve whether a drug manufacturer who has complied with the Food and Drug Administration’s drug labeling requirements can still be liable under a state product liability law claim on the ground that the label was inadequate. The Supreme Court’s decision is important because the Court has the opportunity to clarify federal preemption doctrine. In addition, the outcome is relevant to public health, as the decision will clarify the scope of drug manufacturers’ responsibilities to patients and doctors.
· Drug and Device Law Blog: Views on issues related to pharmaceutical and medical device product liability litigation.
· Pharmaceutical and Medical Devices: Fulbright & Jaworski L.L.P. Briefing on Wyeth v. Levine.
· Drug Injury Watch Blog:. Information about prescription drug side effects.